Easy Medical Device Podcast

Sponsor Medboard 

Medboard: https://www.medboard.com/

EUROPE

Europe Starts Regulating the Regulators - Implementing Regulation (EU) 2026/977: https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

EUDAMED is mandatory - Panic is raising: https://health.ec.europa.eu/medical-devices-eudamed/overview_en

Germany: https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/DMIDS-anleitung-anzeigepflichtige-mp-ivd.pdf?__blob=publicationFile

Belgium: https://www.famhp.be/en/news/eudamed_clarifications_regarding_obligations_from_28_may_2026
Portugal: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/13092901

AI Medical Devices - Timeline changed for AI ACT: https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/

Germany guidance: https://www.bundesnetzagentur.de/DE/Fachthemen/Digitales/KI/5_Innovationen/_DL/Roadmap_Pilot.pdf?__blob=publicationFile&v=5

Spain new HTA - Royal Decree 415/2026: https://www.boe.es/boe/dias/2026/05/29/pdfs/BOE-A-2026-11587.pdf

Denmark on languages - Reminder that there are requirements to follow: https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/

UK

MHRA regulatory advice meetings - Pay and ask what you want: https://www.gov.uk/guidance/medical-devices-ask-for-a-regulatory-advice-meeting-from-the-mhra

Easy Medical Device solutions

EasyIFU - electronic Instruction for Use: https://easyifu.com

Smarteye - electronic Quality Management System: https://eqms-smarteye.com/

Rest of the World

FDA reinforce Human Factors expectations - This is not nice to have: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions

Saudi Arabia bundling criteria - More products in a single application: https://www.sfda.gov.sa/sites/default/files/2026-05/MDS-G28.pdf

Podcast

Podcast Nostalgia - Re-listen latest podcast episodes:

Episode 390 - How can a proper intended use save your device with Kanrandeep Badwal: https://podcast.easymedicaldevice.com/390-2/

Episode 391 - Feedback after 3 months of the new FDA QMSR is in place with Mathangi Srinivasan: https://podcast.easymedicaldevice.com/391-2/

Easy Medical Device

Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/

BOSS Program: Back Office Services

eQMS: https://easymedicaldevice.com/smarteye-eqms/

EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/

Authorized Representative in EU, UK and Switzerland

Market access all over the world: https://easymedicaldevice.com/services/market-access/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly 30 years.

Three months later, the reality is becoming clear for many manufacturers:
QMSR is far more than a simple regulatory update.

It represents a complete transformation in how the FDA expects companies to manage quality, risk, design controls, manufacturing, supplier oversight, and post-market surveillance.

From Siloed Quality to Lifecycle Thinking

Under the old QSR framework, companies often treated quality activities separately:

Design controls

CAPA

Manufacturing

Supplier management

Post-market surveillance

QMSR changes this mindset entirely.

FDA now expects manufacturers to demonstrate integrated, risk-based quality management across the entire product lifecycle.

This means:

Design changes must connect to manufacturing validation

Supplier issues must feed into risk management

Post-market surveillance must proactively identify trends

Management reviews must show real decision-making

Why Many Companies Were Not Ready

A major misconception across the industry was believing that ISO 13485 certification automatically meant QMSR readiness.

But manufacturers are now discovering major gaps:

Incomplete Design History Files (DHF)

Weak risk integration

Poor documentation traceability

Reactive PMS systems

Limited management review evidence

FDA inspections are already reflecting these expectations.

Inspectors are requesting:

Internal audit reports

Supplier audit documentation

Management review records

Risk-based decision evidence

This level of transparency is new for many organizations.

Real-World Challenges Manufacturers Are Facing

One of the biggest pain points is DHF restructuring.

Companies with years of design changes are now being forced to reconstruct the logic behind historical decisions and organize fragmented information into a coherent, risk-based structure.

Another major shift is Post-Market Surveillance.

QMSR pushes manufacturers from reactive complaint handling toward proactive monitoring of known high-risk failure modes using trend analysis, registries, and real-world data.

Management review processes are also under greater scrutiny.
FDA now expects leadership teams to demonstrate how quality data drives actual strategic decisions.

Best Practices for QMSR Transition

Manufacturers preparing for QMSR should focus on:

1. Cross-functional collaboration

Break down silos between QA, RA, Manufacturing, Design, and Supply Chain.

2. Documentation mapping

Identify where critical design logic and risk decisions currently exist.

3. Continuous risk management

Implement ongoing cross-functional risk review meetings.

4. Stronger internal audits

Move beyond checklist auditing toward analytical risk-focused auditing.

5. Meaningful management reviews

Use management review meetings to demonstrate active leadership involvement in quality decisions.

Final Thoughts

QMSR is fundamentally changing the FDA’s expectations.

Companies that adapt early will build stronger systems, improve product quality, and reduce regulatory risk.

Companies that delay may face:

FDA 483 observations

Warning Letters

Product launch delays

Increased remediation costs

The transition to QMSR is not simply a compliance project.

It is a complete redesign of how medical device companies manage quality.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Mathangi Srinivasan linkedin: https://www.linkedin.com/in/mathangiks/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy.

In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.

The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.

The episode also provides practical guidance for manufacturers on:

Defining a robust intended use statement

Aligning intended use with clinical evidence and risk management

Avoiding “labeling tricks” that may trigger regulatory scrutiny

Building internal collaboration between regulatory, clinical, and product teams

This is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

karandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/

qra-medical linkedin: https://www.linkedin.com/company/qra-medical/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Sponsor: Medboard

https://www.medboard.com/

Europe

EUDAMED: It's Go Time -May 28th 2026 for New Products: 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639

https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf

Brand new Notified Body Rules -Implementation regulation 2026/977

https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

https://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/

EU MDR IVDR Simplification Proposal - 2 tracks

https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2025/1023/COM_COM(2025)1023_EN.pdf

EMA Breakthrough Medical Devices Pilot  - Just launched

https://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-devices

https://www.ema.europa.eu/en/documents/presentation/presentation-breakthrough-medical-devices-pilot-information-sessio_en.pdf

MIR form update - Update your files or links:

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en

Switzerland

Swissdamed device Registration - July 1st is coming

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.html

Swissmedic's 2026 PMS Focus Campaign - Class Iia, Iib and III

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/info-ueberpruefung-dokumentation-zur-ueberwachung-nach-inverkehrbringen.html

UK

MHRA proposes indefinite CE Mark Recognition - Poll is closed

https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices

New UK Clinical Trials Framework -Live Since April 28th

https://www.gov.uk/government/news/launch-of-clinical-trial-reforms

New MHRA fees + Faster Incident Reporting -  Reminder to budget and update procedures.

https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees

https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirements

MHRA Medical Devices (Amendment) Regulations 2026 - Brand New, Your Input Needed

https://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation

Events

Medtech Summit - June 15-16, 2026 in Berlin, Germany

https://informaconnect.com/medtech-summit

European Medical Device Supplier Excellence Conference - June 9-11th, 2026 - Brussels, Belgium

https://medicaldevicesupplierexcellence.com/

International

USA — FDA Launches -  AI Platform HALO and Upgrades Elsa to 4.0

https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation

Canada: Two changes happening —  Mandatory Digital Submissions + New AI/ML Device Guidance

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/mandatory-use-regulatory-enrolment-process-notice-to-industry.html

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf

Podcast

Podcast Nostalgia  

Episode 384: AI Medical Devices: What Notified Bodies Really Look for (Camille Petri): https://podcast.easymedicaldevice.com/384-2/

Episode 385: The Fake QMS Problem: Why your ISO 13485 System will fail and Audit: https://podcast.easymedicaldevice.com/385-2/

Episode 386: Life after CE Marking: Why AI Medical Devices Need Continuous Monitoring (Osman El-Kouban): https://podcast.easymedicaldevice.com/386-2/

Episode 387: Master UDI-DI: The New Layer many Medtech Companies don't Understand (Hussam Mostafa):  https://podcast.easymedicaldevice.com/387-2/

Episode 388: Certifying LLM-Driven medical devices (Sandy Wright): https://podcast.easymedicaldevice.com/388-2/

Easy Medical Device

Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/

BOSS Program: Back Office Services

eQMS: https://easymedicaldevice.com/smarteye-eqms/

EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/

Authorized Representative in EU, UK and Switzerland

Market access all over the world: https://easymedicaldevice.com/services/market-access/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Unique Device Identification (UDI) has become a central element of medical device compliance worldwide.

From EUDAMED in Europe to FDA databases in the United States, regulators increasingly rely on accurate UDI data to improve traceability and patient safety.

But many manufacturers underestimate one important reality:

👉 A small UDI mistake can become extremely expensive.

Why UDI Accuracy Matters

UDI is not simply a number placed on a label.
It is a structured identification system connected to:

• Device traceability
• Regulatory databases
• Market surveillance
• Recalls
• Post-market monitoring

When UDI data is incorrect or incomplete, the impact can quickly spread across the entire quality and regulatory system.

The Real Risks of Incorrect UDI Data

An incorrectly calculated or poorly structured UDI can lead to:

Product Recalls

If products cannot be correctly identified, companies may need to perform recalls or field actions.

Database Errors

Incorrect submissions to EUDAMED or FDA databases may prevent customers and authorities from accessing accurate device information.

Traceability Gaps

Without proper identification, tracking affected products becomes difficult during complaints or vigilance activities.

Financial Costs

Fixing UDI errors after commercialization often requires:
• Relabeling
• Database corrections
• Regulatory updates
• Internal investigations

All of these consume significant time and resources.

Why Many Companies Struggle

UDI implementation often requires coordination between:
• Regulatory Affairs
• Quality
• Supply Chain
• IT
• Manufacturing

Many organizations discover inconsistencies in:
• Device families
• Packaging hierarchies
• Certificates
• Product configurations

Without strong governance, errors become inevitable.

Best Practices to Avoid UDI Problems

Manufacturers should:

✔ Validate UDI structures early
✔ Review regulatory guidance carefully
✔ Audit device data regularly
✔ Test database submissions before launch
✔ Ensure cross-functional ownership of UDI data

Final Thought

UDI mistakes are rarely “small” problems.

In MedTech, inaccurate identification can affect compliance, operational efficiency, and ultimately patient safety.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Sandy LinkedIn: https://www.linkedin.com/in/wrightsandy/

Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.

Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.

Understanding the UDI Structure

To fully understand Master UDI-DI, it’s important to distinguish between the different levels:

• UDI-DI → Identifies a specific device
• Basic UDI-DI → Groups devices with the same intended purpose and characteristics
• Master UDI-DI → Applies to highly individualized devices with specific design parameters

This new layer aims to better manage products with high variability.

Why Master UDI-DI Was Introduced

For certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.

Master UDI-DI helps:
• Reduce the number of identifiers required
• Improve traceability
• Simplify product grouping
• Enhance recall efficiency

Key Benefits

Despite its complexity, Master UDI-DI brings several advantages:

✔ Better organization of device data
✔ Improved market surveillance
✔ Faster identification during recalls
✔ Stronger protection against counterfeit products

Challenges for Manufacturers

However, the implementation is not without challenges:

• Increased data requirements
• Risk of incorrect UDI assignment
• Need for cross-functional coordination
• Integration with EUDAMED

As highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.

Timeline and Urgency

While the labeling deadline is set for November 2028, manufacturers should not wait.

EUDAMED requirements are already active, and preparation takes time.

👉 Early implementation reduces risk, cost, and operational pressure.

Best Practices

To ensure compliance, manufacturers should:

• Study MDCG guidance documents
• Validate data before submission
• Use tools for UDI calculation
• Involve project managers and cross-functional teams
• Seek expert support when needed

Who is Al Hajj Sam Mostafa? 

Al Hajj Sam Mostafa is founder and CEO of UDI Experts. He has nearly 10 years of UDI experience, in which he leads and provides his premiere UDI solutions to MedTech organizations. One of his prestige clients is of the Magnificent Seven (Big Tech) companies. UDI Experts continuously strives to offer their clients the best UDI services for the best prices. Their global services include medical device data collection, data registration, UDI label creation and UDI label support, UDI printing IQ/OQ/PQ, and much more. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Website: www.udiexperts.com

Business LinkedIn: www.linkedin.com/in/udi-experts-600138189           

Personal LinkedIn: www.linkedin.com/in/al-hajj-sam-m-03b69612

YouTube UDI Video for Dawa Medical  (below)

Import IQ: Episode 5 Understanding the UDI with Hussam Mustafa 

UDI Experts YouTube Channel: www.youtube.com/@UDIExperts-o3z

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.

In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.

CE Certification Is Not the Finish Line

Many companies assume that once their device is certified, the main regulatory burden is over.

In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions.

Relaxing after certification can lead to:
• Loss of control over performance
• Undetected risks
• Regulatory non-compliance

AI in the Real World: Performance Drift

AI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time.

Manufacturers must implement continuous monitoring strategies, including:
• Real-world data (RWD) collection
• Performance tracking
• Feedback loops for improvement

Updating AI Devices: What Is Allowed?

Updating AI systems introduces regulatory complexity.

Key questions include:
• What qualifies as a significant change?
• Does retraining require re-certification?
• How should updates be documented and justified?

Manufacturers often struggle with these decisions, leading to compliance risks.

PCCP: Enabling Controlled Evolution

The concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve.

While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration.

Building a Mature AI PMS System

A robust post-market system for AI devices should include:
• Continuous performance monitoring
• Risk management integration
• Clear documentation of updates
• Strong governance of data and models

Who is Osman El-Koubani

Dr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Many medical device companies believe they have a compliant Quality Management System (QMS).

On paper, everything looks perfect:
• Procedures are written
• Forms are available
• Risk management is documented
• CAPA systems are defined

But during an audit, everything falls apart.

What Is a “Fake QMS”?

A fake QMS is not necessarily incorrect — it is simply not implemented in reality.

Employees may not understand it.
Processes may not be followed.
Evidence may not exist.

In short:
👉 The system exists… but it is not alive.

Why This Happens

There are three common causes:

1. Copy-Paste Systems

Companies reuse QMS from other organizations without adapting them to their own operations.

2. Template-Based QMS

Generic ISO 13485 packages provide documentation — but no real implementation.

3. Consultant-Driven Systems

Consultants build the QMS, but knowledge is never transferred internally.

When they leave, the system collapses.

What Happens During an Audit

Auditors don’t just review documents — they test your system.

Examples include:

• CAPA: Can you explain root cause analysis?
• Risk Management: Do you link PMS data to risk updates?
• Training: Do employees understand their responsibilities?

If the answer is no, nonconformities follow.

The Core Problem

A QMS is not documentation.

👉 It is a living system based on real processes and evidence.

How to Build a Real QMS

To avoid this trap, companies should:

• Build processes based on real operations
• Keep procedures simple and usable
• Define clear responsibilities
• Train employees effectively
• Create traceable evidence
• Use an eQMS for control and integration
• Test the system internally before audits

Final Takeaway

A fake QMS is not just a compliance issue — it is a business risk.

It can lead to:
• Audit failures
• Delays in certification
• Loss of credibility

ISO 13485 is not about having documents.
👉 It’s about proving that your system works.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased regulatory complexity.

In this episode, Camille Petri shares insights into how Notified Bodies assess AI-based medical devices and what manufacturers need to prepare for successful certification.

Are AI Devices More Difficult to Certify?

Compared to traditional software, AI-based medical devices introduce additional layers of complexity. These include data dependency, algorithm behavior, and potential variability in performance.

Notified Bodies are therefore placing greater emphasis on transparency, traceability, and robustness.

Data: The Foundation of AI Certification

One of the most critical elements in AI certification is the quality of data.

Manufacturers must clearly document:
• Training datasets
• Validation datasets
• Test datasets

Common deficiencies include poor dataset representativeness, lack of traceability, and insufficient justification of data selection.

Clinical Evaluation for AI

Clinical evaluation for AI devices differs from traditional approaches.

Regulators may accept retrospective data in some cases, but increasingly expect strong clinical evidence demonstrating real-world performance.

The challenge lies in proving that the AI system performs consistently across different populations and use cases.

Risk Management in AI

AI introduces new types of risks, including:
• Algorithm bias
• Performance drift over time
• Lack of explainability

Manufacturers must integrate these risks into their risk management process, in line with ISO 14971.

Performance, Validation & Continuous Learning

A key question for regulators is how to manage AI systems that evolve over time.

Notified Bodies often differentiate between:
• Locked algorithms (fixed behavior)
• Continuous learning systems (adaptive models)

Each approach has different regulatory implications, particularly regarding validation and post-market monitoring.

Key Takeaway

AI in MedTech offers tremendous opportunities, but certification requires a strong foundation in data, clinical evidence, and risk management.

Understanding what Notified Bodies expect early in development can significantly improve your chances of a successful submission.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Camille Petri Linkedin: https://www.linkedin.com/in/camillepetri/

Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Medboard

Sponsor: Medboard: https://www.medboard.com/

EU

Extension of WET Class Iib - A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809

Update your MIR form - Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf

UK

Future Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations

Consultation on indefinite recognition of CE marked medical devices and current transitional arrangements

Pre-market Statutory Instrument (SI)

Future Enhancemens: Exceptional Use Authorization and Health Institution exemption

Post-market Surveillance Requirements

Update to guidances

Learn Clinical Investigation in the UK - Lot of questions answered: 

Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devices

Clinical investigations: investigators' responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigators

Clinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerations

Medical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation

Determining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-required

Clinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png

Events

Team NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdf

Egypt: Vigilance reporting Training - April 7 to 9, 2026: https://tinyurl.com/emdpodcast

MedtechConf.com - Check the MAPEU

Swiss Medtech Day 2026 - June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/

Medtech Forum - May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/

US

Veeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/

Brazil

Hospitalar - May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/

RoW

Australia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australia

Your advertisement must contain:

an accurate description of the device

the trade name of the device

the intended purpose(s) of the device

any mandatory statements and, where relevant, health warnings.

For example, you must not:

claim your product is “TGA approved”

make unsubstantiated claims about the product’s performance

include endorsements or testimonials from health professionals or medical researchers.

Malaysia: Guidance Creation/Update - Medical Device Act 2012 

Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devices

Guidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devices

Guidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-application

India: FAQ on IVD products - 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdf

Egypt: What you need to register - List of documents: https://tinyurl.com/EmdEgyptRegistration

Podcast

Podcast Nostalgia -Let's remember: https://podcast.easymedicaldevice.com/

Episode 381: EUDAMED deadline 2026:  https://podcast.easymedicaldevice.com/381-2/

Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/

Service

New Website: https://easymedicaldevice.com

Authorized Representative

Consulting

Training

EasyIFU: https://easyifu.com

Smarteye: https://eqms-smarteye.com/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.